Bioagent Export Control List
This list is subject to change (Current as of December 2014).
Per the Export Administration Regulations (EAR; Category 1 – Materials, Chemicals, Microorganisms and Toxins, last updated 2013-10-15), a license will be required to export the following bioagents. Other export controls may apply for possession and use in the U.S.
For more information see the UF Office of Research web page on Export Controls.
Note: These ECCNs control all biological agents and toxins, regardless of quantity or attenuation, that are identified in the List of Items Controlled for the ECCN, including small quantities or attenuated strains of select biological agents and toxins that are excluded from the lists of select biological agents and toxins by APHIS, the CDC and HHS (7 CFR 331, 9 CFR 121, and 42 CFR 73).
While many of these items are select agents, those preceded by an asterisk(*) are not, but still require an export permit.
Human and Animal Pathogens (ECCN 1C351 & 1C352)
- 1918 pandemic influenza virus – reconstructed replication competent forms containing any portion of the coding regions of all 8 gene segments.
- African horse sickness virus
- African swine fever virus
- *Andes virus
- Avian influenza (AI) viruses identified as having high pathogenicity (HP), as follows:
- AI viruses that have an intravenous pathogenicity index (IVPI) in 6-233k old chickens >1.2 or
- AI viruses that cause at least 75% mortality in 4- to 8-week old chickens infected IV.
Note: Avian influenza viruses of the H5 or H7 subtype that do not have either of the characteristics described above should be sequenced to determine whether multiple basic amino acids are present at the cleavage site of the haemagglutinin molecule (HAO). If the amino acid motif is similar to that observed for other HPAI isolates, then the isolate being tested should be considered HPAI and the virus is controlled under 1C352.a.2.
- *Blue tongue virus
- Chapare virus
- *Chikungunya virus
- *Choclo virus
- Congo-Crimean haemorrhagic fever virus
- *Dengue fever virus
- *Dobrava-Belgrade virus
- Eastern equine encephalitis virus
- Ebola virus
- Foot and mouth disease virus
- Goat pox virus
- Guanarito virus
- *Hantaan virus
- Hendra virus (Equine morbillivirus)
- Hog cholera virus (Classical swine fever virus)
- *Japanese encephalitis virus
- Junin virus
- Kyasanur Forest virus
- *Laguna Negra virus
- Lassa fever virus
- *Louping ill virus
- Lujo virus
- Lumpy skin disease virus
- *Lymphocytic choriomeningitis virus
- Machupo virus
- Marburg virus
- Monkey pox virus
- *Murray Valley encephalitis virus
- Newcastle disease virus
- Nipah virus
- Omsk haemorrhagic fever virus
- *Oropouche virus
- Peste des petits ruminants virus
- Porcine enterovirus type 9 (swine vesicular disease virus)
- *Porcine herpes virus (Aujeszky’s disease)
- *Powassan virus
- Rabies virus and all other members of the Lyssavirus genus
- Rift Valley fever virus
- Rinderpest virus
- *Rocio virus
- Sabia virus
- SARS-associated coronavirus (SARS-CoV)
- *Seoul virus
- Sheep pox virus
- *Sin Nombre virus
- *St. Louis encephalitis virus
- *Teschen disease virus
- Tickborne encephalitis virus (Far eastern subtype, formerly Russian Spring-Summer encephalitis virus)
- Tickborne encephalitis virus (Siberian subtype, formerly West Siberian virus)
- Variola virus
- Venezuelan equine encephalitis virus
- *Vesicular stomatitis virus
- *Western equine encephalitis virus
- *Yellow fever virus
Bacterial, Fungal and Rickettsial Agents
- Bacillus anthracis
- Brucella abortis
- Brucella melitensis
- Brucella suis
- Burkholderia mallei (Pseudomonas mallei)
- Burkholderia pseudomallei (Pseudomonas pseudomallei)
- *Chlamydophila psittaci (formerly Chlamydia psittaci)
- Clostridium argentinense (formerly Clostridium botulinum Type G), botulinum neurotoxin producing strains
- Clostridium baratii, botulinum neurotoxin producing strains
- Clostridium botulinum
- Clostridium butyricum, botulinum neurotoxin producing strains
- *Clostridium perfringens, epsilon toxin producing types
- *Coccidioides immitis
- *Coccidioides posadasii
- Coxiella burnetii
- Francisella tularensis
- Mycoplasma capricolum subspecies capripneumoniae (“strain F38”)
- Mycoplasma mycoides subspecies mycoides SC (small colony, contagious bone pleuropneumonia)
- Rickettsia prowazekii
- *Rickettsia rickettsia
- *Salmonella typhi
- *Shiga toxin producing Eschericia coli (STEC; a.k.a. enterohaemorrhagic E. coli (EHEC) or verocytotoxin-producing E. coli (VTEC)) of serogroups O26, O45, O103, O104, O111, O121, O145, O157 and other Shiga toxin producing serogroups
- *Shigella dysenteriae
- *Vibrio cholera
- Yersinia pestis
Biological Toxins and subunits thereof
- Botulinum toxins
- *Cholera toxin
- *Clostridium perfringens alpha, beta 1, beta 2, epsilon and iota toxins
- Diacetosyscirpenol toxin
- *HT-2 toxin
- *Microcystin (Cyanginosin)
- *Modeccin toxin
- *Shiga toxin
- Staphylococcus aureus enterotoxins, hemolysin alpha toxin, and toxic shock syndrome toxin (formerly Staphylococcus enterotoxin F)
- T-2 toxin
- *Verotoxin and other Shiga-like ribosome inactivating proteins
- *Viscum Ablum Lectin 1 (Viscumin)
- *Volkensin toxin
$The following forms of ricin and saxitoxin are CWC Schedule 1 chemicals (see 742.18 of the EAR) and require a license for CW reasons to export and reexport to all destinations including Canada:
- Ricin in the form of Ricinus Communis AgglutininII (RCAII; aka: ricin D or Ricinus Communis LectinIII (RCLIII)) and Ricinus Communis LectinIV (RCLIV; aka ricin E).
- Saxitoxin identified by C.A.S. #35523-89-8
The US Government must provide advance notification and annual reports to the OPWC of all exports of Schedule 1 chemicals (see 745.0 of the EAR for notification procedures).
#While only saxitoxin is controlled on the CCL, other members of the paralytic shellfish poison family (e.g., neosaxitoxin) are designated EAR99 (see below).
Plant Pathogens (ECCN 1C354)
- *Andean potato latent virus (Potato Andean latent tymovirus)
- *Clavibacter michiganensis subspecies sepedonicus (Corynebacterium michiganensis subspecies sepedonicum or Corynebacterium sepedonicum)
- *Cochliobolus miyabeanus (Helminthosporium oryzae)
- *Colletotrichium kahawae (Colletotrichium coffeanum var. virulans)
- *Magnaporthe oryzae (Pyricularia oryzae)
- *Microcyclus ulei (Dothidella ulei)
- Peronosclerospora philippinensis (Peronosclerospora sachhari)
- Phoma glycinicola (formerly Pyrenochaeta glycines)
- *Potato spindle tuber viroid
- *Puccinia graminis ssp. Graminis var. graminis/Puccina graminis ssp. Graminis car. Stakmanii (Puccinia graminis [syn. Puccinia graminis f.sp. Tritici])
- *Puccinia striiformia (Puccinia glumarum)
- Ralstonia solanacearum, race 3, biovar 2 (Burkholderia solanacearum, race 3, biovar 2)
- Rathayibacter toxicus
- Sclerphthora rayssiae var. zeae
- Synchytrium endobioticum
- *Thecaphora solani
- *Tilletia indica
- *Xanthomonas albilineans
- *Xanthomonas axonopodis pv. Citri (Xanthomonas campestris pv. Citri A) (Xanthomonas campestris pv. Citri)
- Xanthomonas oryzae
Genetic Elements and genetically modified organisms (ECCN 1C353)
- Genetic elements that contain nucleic acid sequences associated with the pathogenicity of microorganisms controlled by 1C351.a to .c, 1C352 and 1C354.
- Genetic elements that contain nucleic acid sequences coding for any of the “toxins” controlled by 1C351.d or “sub-units of toxins” thereof.
Genetically modified organisms
- Genetically modified organisms that contain nucleic acid sequences associated with the pathogenicity of microorganism controlled by 1C351.a to .c, 1C352 and 1C354.
- Genetically modified organisms that contain nucleic acid sequences coding for any of the “toxins” controlled by 1C351.d or “sub-units of toxins” thereof.
- “Genetic elements” include, inter alia, chromosomes, genomes, plasmids, transposons, and vectors, whether genetically modified or unmodified, or chemically synthesized in whole or in part.
- This ECCN does not control nucleic acid sequences associated with the pathogenicity of enterohaemorrhagic Eschericia coli, serotype O157 and other verotoxin producing strains, except those nucleic acids that contain coding for the verotoxin or its sub-units.
- “Nucleic acid sequences associated with the pathogenicity of any of the microorganisms controlled by 1C352.a to .c, 1C352, or 1C354” means any sequence specific to the relevant controlled microorganism that:
- In itself or through its transcribed or translated products represents a significant hazard to human, animal or plant health; or
- Is known to enhance the ability of a microorganism controlled by 1C352.a to .c, 1C352, or 1C354, or any other organism into which it may be inserted or otherwise integrated, to cause serious harm to human, animal or plant health.
- “Genetically modified organisms” include organisms in which the genetic material (nucleic acid sequences) has been altered in a way that does not occur naturally by mating and/or natural recombination, and encompasses those produced artificially in whole or in part.
As a result of recent changes to the CDC/APHIS list of Select Agents and Toxins, the following select agents that were formerly controlled by ECCN 1C360 are no longer listed on the CCL and are now classified as EAR99 instead:
- Central European Tickborne encephalitis viruses:
- Absettarov virus
- Hanzalova virus
- Hypr virus
- Kumlinge virus
- Cercopithecine herpesvirus 1 (Herpes B virus)
- Flexal virus
- Akabane virus
- Bovine spongiform encephalopathy agent
- Camel pox virus
- Malignant catarrhal fever virus
- Menangle virus
- Erhlichia ruminantium (a.k.a. Cowdria rumunantium)
- Xylella fastidiosa pv. citrus variegated chlorosis (CVC)
Items designated as EAR99 may be exported using the license exception NLR, specifying no license requires, as long ALL of the following criteria are met:
- The item is not being shipped to a sanctioned destination;
- The item is not being shipped to a denied person, sanctioned entity or prohibited end-user; and
- The item will not be used for a specific end-use, subject to higher controls.
International Traffic in Arms Regulations (ITAR)
MULTIPLE Export Controls, INCLUDING a License will be required to use or possess the following:
(b) Biological agents and biologically derived substances specifically developed, configured, adapted, or modified for the purpose of increasing their capability to produce casualties in humans or livestock, degrade equipment or damage crops.
(f) Equipment and its components, parts, accessories, and attachments specifically designed or modified for military operations and compatibility with military equipment as follows:
- The dissemination, dispersion or testing of the biological agents listed in paragraph (b);
- The detection, identification, warning or monitoring of the biological agents listed in paragraph (b);
- Sample collection and processing of the biological agents listed in paragraph (b);
- Individual protection against the biological agents listed in paragraph (b);
- Collective protection against the biological agents listed in paragraph (b);
- Decontamination or remediation of the biological agents listed in paragraph (b).
Additional items associated with, or specific to, the biological agents listed in paragraph (b) are also controlled under the ITAR including medical countermeasures (pre- and post-treatments, vaccines, antidotes, medical diagnostics); modeling or simulation tools; equipment, components, parts, accessories and attachments, exclusive of incinerators specifically designed/modified for the destruction of biological agents in paragraph (b); technical data and defense services. For more information on these items please refer to Category XIV – Toxicological Agents, including Chemical Agents, Biological Agents and Associated Equipment sections (g) through (m), page 486.